Insulin Aspart

INSULIN ASPART- insulin aspart injection, solution
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

Insulin aspart is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Always check insulin labels before administration [see Warnings and Precautions ( 5.4)] .
  • Inspect insulin aspart visually before use. It should appear clear and colorless. Do not use insulin aspart if particulate matter or coloration is seen.
  • Use Insulin Aspart FlexPen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.Use Insulin Aspart FlexPen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
  • Use PenFill cartridges with caution in patients with visual impairment.Use PenFill cartridges with caution in patients with visual impairment.
  • Do NOT mix insulin aspart with other insulins when administering using a continuous subcutaneous infusion pump.

2.2 Route of Administration

Subcutaneous Injection

  • Inject insulin aspart subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
  • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2) and Adverse Reactions ( 6.1, 6.3)]. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2) and Adverse Reactions ( 6.1, 6.3)].
  • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2)]. During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2)].
  • The Insulin Aspart FlexPen dial in 1-unit increments. The Insulin Aspart FlexPen dial in 1-unit increments.
  • Insulin aspart administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.
  • Insulin aspart may be diluted with Insulin Diluting Medium for NovoLog ® for subcutaneous injection. Diluting one part insulin aspart to nine parts diluent will yield a concentration one-tenth that of insulin aspart (equivalent to U-10). Diluting one part insulin aspart to one part diluent will yield a concentration one-half that of insulin aspart (equivalent to U-50).

Continuous Subcutaneous Infusion (Insulin Pump)

  • Use insulin aspart in pump systems specifically indicated for insulin infusion.Use insulin aspart in pump systems specifically indicated for insulin infusion.
  • Train patients using continuous subcutaneous insulin fusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
  • Administer insulin aspart by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2) and Adverse Reactions ( 6.1, 6.3)]. Administer insulin aspart by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2) and Adverse Reactions (6.1, 6.3)].
  • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2)]. During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2)].
  • Follow healthcare provider recommendations when setting basal and meal time infusion rate.
  • Change the insulin aspart in the reservoir at least every 6 days. Follow the insulin aspart-specific information for in-use time because insulin aspart-specific information may differ from general pump manual instructions.Change the insulin aspart in the reservoir at least every 6 days. Follow the insulin aspart-specific information for in-use time because insulin aspart-specific information may differ from general pump manual instructions.
  • Change the infusion set and the infusion set insertion site at least every 3 days. Change the infusion set and the infusion set insertion site at least every 3 days.
  • Do NOT dilute or mix insulin aspart when administering by continuous subcutaneous infusion.Do NOT dilute or mix insulin aspart when administering by continuous subcutaneous infusion.
  • Do NOT expose insulin aspart in the pump reservoir to temperatures greater than 98.6°F (37°C).

Intravenous Administration

  • Dilute insulin aspart to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. Insulin aspart is stable in infusion fluids such as 0.9% sodium chloride.
  • Administer insulin aspart intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3, 5.6) and How Supplied/Storage and Handling ( 16.2)] .

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